Pharmaceutical News: Cancer Drug Developers Considering ImmunoGen’s Tap Technology

Cancer Drug Developers Considering ImmunoGen’s Tap Technology

Something to think about: The fact that using ImmunoGen’s (IMGN) TAP technology makes targeted cancer drugs beat their own efficacy. This reality seems to be increasingly considered by cancer drug developers. Using ImmunoGen’s technology enables approved, or investigational targeted cancer drugs developed by pharmaceutical companies to gain extra-efficacy as first line treatments, in addition to overcoming cancer resistance in case of recurrences. The oncology drug developers would love to see their same products bring better safety and efficacy, cover more patients and succeed if recurrences occur.

Yesterday, after the end of the market session, ImmunoGen announced it has earned a $2 million milestone payment after Bayer HealthCare Pharmaceuticals, submitted an investigational new drug application for its cancer drug BAY 94-9343 in development using Immunogen’s technology. The drug is a promising therapeutic for mesothelin-expressing cancers. Daniel Junius, ImmunoGen President and CEO said, “In addition to BAY 94-9343, we expect five other TAP compounds to advance into clinical testing in the next twelve months – two developed and wholly owned by ImmunoGen and three through our collaborations with other companies. Overall, we anticipate that there will be twelve TAP compounds in the clinic by this time next year.”

Mesothelin is highly expressed on mesotheliomas and on many ovarian and pancreatic carcinomas. BAY 94-9343 consists of a Bayer HealthCare antibody that targets mesothelin with ImmunoGen’s DM4 cancer-cell killing agent attached, using one of ImmunoGen’s engineered linkers. In preclinical testing, BAY 94-9343 demonstrated potent, targeted anticancer activity against mesothelin-expressing tumors.

ImmunoGen has granted Bayer HealthCare exclusive rights to use ImmunoGen’s maytansinoid TAP technology to develop anticancer treatments that target mesothelin. ImmunoGen is entitled to receive milestone payments potentially totaling up to $170.5 million for each resulting product, plus royalties on sales.

This is not all. More agreements are expected to be signed with other firms following the validation of ImmunoGen’s technological capability. The validation emanated from previously announced results, especially, with T-DM1, with Roche’s drug Herceptin incorporated into the TAP drug for HER2 breast cancer. The technology is being validated in preclinical experimentation as with Bayers’ drug BAY 94-9343 and five other TAP compounds that are advancing into clinical testing.

These new products add to ImmunoGen’s pipeline products that are already in mid- and late- clinical trials. Two of the newly comer drugs will be added to the products that are wholly owned by ImmunoGen.

APP Pharma to Plug $38M into Expanding NY Manufacturing Site

APP Pharmaceuticals plans on investing $38 million to exapnd a manufacturing facility in Grand Island, NY, to increase its production of injectable genetic drugs. It will thus add 90 jobs to its existing workforce of 580 at the plant.

APP, a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, will expand its production site by 13,000 square feet and add six new production lines for injectable products. The expansion is anticipated to begin this month and take two years to complete.

At Grand Island, APP manufactures a variety of injectable pharmaceutical products for the North America market. The products encompass four therapeutic areas: anti-infectives, critical care, analgesia/anesthesia, and oncology.

“Through the expansion, the site will significantly contribute to the continuous local supply of high-quality injectable generics for the U.S. and Canada,” states Michael Schönhofen, president, science, production, and technology for Fresenius Kabi.

Based on its promise of the new and retained jobs, APP has won nearly $1.2 million in tax credits over five years through New York state’s Excelsior Jobs Program; 2,000 kW of lower-cost power through the state Power Authority; and local property tax, sales tax, and mortgage tax abatements through the Erie County Economic Development Corp.

Listed pharmaceutical firms welcome BEE rules for state tenders

Listed drug firms will soon benefit if they are empowered when bidding for state tenders.

This is because health-care procurement has been aligned to all the elements of broad-based black economic empowerment (BEE) following the publication of regulations of the Preferential Procurement Policy Framework Act by the National Treasury last week.

Previously, these companies’ empowerment credentials did not matter because procurement was linked only to equity, which is one element of the BEE scorecard.

While these public firms have empowerment shareholders, the government did not consider these as it was felt that shareholding changed hands regularly on the stock exchange.

But the regulations that are expected to come into effect by December say the points scored by a tenderer in respect of BEE contribution must be added to the points scored for price.

Bidding firms will have to submit their broad-based BEE status level verification certificate or a certified copy thereof, substantiating their rating, except for those that are exempted. In the event that two or more tenders have scored equal total points, the successful tender must be the one scoring the highest number of preference points.

Stavros Nicolaou, Aspen Pharmacare’s senior executive for strategic trade, said it was a major policy shift that the industry had been waiting for.

“Previously they looked at equity ownership and listed companies always scored zero. It didn’t matter where you were on a BEE rating. You could have been a level two, which is highly empowered, going up against a level five; your empowerment credential did not help,” Nicolaou said. “The more empowered you are, the more the benefit on your pricing.”

Recently, Adcock Ingram had a gripe with the Treasury after the results of the latest antiretroviral tender were released because it felt that its BEE status had not been considered properly. The firm concluded a R1.3 billion empowerment equity transaction in which it sold 13 percent of the company to black investors last year.

Jonathan Louw, the chief executive at Adcock, has previously said the group’s BEE partners were locked in for 10 years, meaning that Adcock’s shareholding would not change for at least a decade even though it was listed.

Both companies are level four broad-based BEE contributors. Yesterday, Adcock said it welcomed the regulations.

“This is a significant development for us and a good outcome for our tender business,” Adcock said in a statement.

Nicolaou, who is also the chairman of Pharmaceuticals Made in South Africa, said the company was also excited by the regulations because there were now going to be products set aside for local producers.

“They would take into account the imported element. The devil is in the detail because they have to work out which products should be designated. It is important to work out if you have capacity and capability, for example, it would be pointless to designate certain oncology products because you couldn’t make them in this country.

“The products that must be set aside are the ones that are strategic to the country and high in volumes. Everyone focuses on HIV but there are a lot of other epidemics in this country, the non-communicable diseases, diabetes, blood pressure. They must also have export potential, especially to sub-Saharan Africa,” Nicolaou said.

Cipla Medpro South Africa said it was still analysing the regulations so it could not comment yet. – Business Report

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